Rapid CD­MO growth marks a start to End­points Man­u­fac­tur­ing's first re­port — here's what to ex­pect from our cov­er­age

Wel­come to the first edi­tion of End­points Man­u­fac­tur­ing.

My name’s Con­ner Mitchell, and I’m an as­so­ciate ed­i­tor for End­points News. I joined the team in ear­ly De­cem­ber to cov­er bio­phar­ma’s glob­al man­u­fac­tur­ing beat, and now we’re tak­ing that cov­er­age up an­oth­er lev­el.

From now on, I’ll have a new re­port for you each Thurs­day with a col­umn de­tail­ing the high­lights of the week’s man­u­fac­tur­ing news, the top news sto­ries in one place, and an ex­clu­sive fea­tured spe­cial to End­points Man­u­fac­tur­ing. This fea­ture will like­ly take on a few dif­fer­ent forms, de­pend­ing on the week, but will be a com­pelling way to stay up to date on the lat­est in the in­dus­try, ex­clu­sive to our read­ers.

We in­tend to be the leader in cov­er­ing the bio­phar­ma man­u­fac­tur­ing in­dus­try. For starters, this means that we al­ways want to be on top of the lat­est news, so if there’s some­thing that I should be aware of — good news or bad — don’t hes­i­tate to send those tips my way.

I’ll be keep­ing an eye on a few key ar­eas this year across biotech man­u­fac­tur­ing: the con­tin­ued roll­out of Covid-19 vac­cines and re­lat­ed ther­a­peu­tics, the sta­tus of the var­i­ous sup­ply chains as­so­ci­at­ed with those ther­a­pies, reg­u­la­to­ry ac­tions, how CD­MOs con­tin­ue to evolve af­ter a re­mark­ably busy 2020, the rise of cell and gene ther­a­pies, and if or how FDA over­sight changes un­der the new Biden ad­min­is­tra­tion.

Man­u­fac­tur­ing is at the heart of what turns biotech break­throughs in­to in­no­v­a­tive prod­ucts and block­busters. Every mar­ket­ed drug has to trav­el the dif­fi­cult path from small-scale clin­i­cal tri­al to a com­mer­cial roll­out. How do they do that? Through scal­able man­u­fac­tur­ing — whether in-house or through key part­ners.

Here’s how you can get in touch with me:

Email: con­ner@end­pointsnews.com

For more se­cure doc­u­ments: con­ner­mitchell@pro­ton­mail.com (end-to-end en­crypt­ed email) or Sig­nal (en­crypt­ed mes­sag­ing) at 316-217-3852

Phone: 316-217-3852

This in­dus­try is bustling right now and al­most cer­tain­ly will con­tin­ue to do so for years to come. It’s an ex­cit­ing time for me to jump in and be able to cov­er it, and I look for­ward to talk­ing to many of you along the way!

Fea­tured sto­ry: Catal­ent sees 26% growth in FY ’21 Q2 com­pared to same pe­ri­od in 2020

It clear­ly pays to be one of the biggest biotech man­u­fac­tur­ers in the world.

Catal­ent, the New Jer­sey-based man­u­fac­tur­ing gi­ant, re­port­ed this week that it took in growth of 26% in the sec­ond quar­ter of its 2021 fis­cal year com­pared to the same quar­ter a year pri­or.

Dol­lars to cents, that’s a net rev­enue of $910.8 mil­lion, net earn­ings of $88.4 mil­lion (up 94% from Q2 of FY 20), and an EBIT­DA earn­ings in­crease of 31% ($223.5 mil­lion in Q2 FY 21).

Here’s what led to the big quar­ter, from Catal­ent’s head man:

John Chimin­s­ki

John Chimin­s­ki, Catal­ent CEO: “Our sec­ond quar­ter re­sults re­flect ro­bust or­gan­ic growth in our Bi­o­log­ics seg­ment, and our in­creased guid­ance re­flects our ex­pec­ta­tion of con­tin­ued strong re­sults for these of­fer­ings for the re­main­der of our fis­cal year. Ad­di­tion­al ca­pac­i­ty in our drug prod­uct and drug sub­stance of­fer­ings will come on line in the sec­ond half of our fis­cal year to help fight the pan­dem­ic and serve oth­er crit­i­cal pa­tient needs.”

In­deed, Catal­ent’s bi­o­log­ics fo­cus saw mas­sive gains on the quar­ter. Net bi­o­log­ics rev­enue hit $403.9 mil­lion, a 79% in­crease from Q2 FY 20, and ac­counts for 44% of the com­pa­ny’s to­tal net rev­enue for the quar­ter.

The one area of Catal­ent’s bal­ance sheet that saw a de­crease in the quar­ter from the year pri­or came in soft­gel and oral tech­nolo­gies, which, while still ac­count­ing for $246.6 mil­lion in net rev­enue (27% of the com­pa­ny’s to­tal for the quar­ter), was a de­crease of 8% from Q2 FY 20.

Fi­nal­ly, Catal­ent re­port­ed a 19% in­crease in oral and spe­cial­ty de­liv­ery rev­enue, rak­ing in $169.9 mil­lion for 19% of the quar­ter’s to­tal net rev­enue.

The pos­i­tive quar­ter al­so al­lowed Catal­ent to in­crease its over­all pro­jec­tions for the en­tire fis­cal year. Now, the man­u­fac­tur­ing gi­ant is pro­ject­ing a net rev­enue be­tween $3.80 bil­lion and $3.95 bil­lion, com­pared to the pre­vi­ous range of $3.58 bil­lion to $3.78 bil­lion.

This week (and year) in man­u­fac­tur­ing

The news this week in bio­phar­ma man­u­fac­tur­ing was slow­er com­pared to the break­neck pace of the start of 2021 — but there are sev­er­al items of note.

WuXi AppTech’s sub­sidiary com­pa­ny WuXi STA an­nounced plans to ac­quire a Bris­tol My­ers Squibb fa­cil­i­ty in Cou­vet, Switzer­land, the com­pa­ny’s first foot­print in the Eu­ro CD­MO mar­ket­place. And the first half of this week saw two re­al­ly in­ter­est­ing pieces of man­u­fac­tur­ing news: First, Celli­no Biotech, a re­gen­er­a­tive med­i­cine start­up in the Boston-area biotech hub, un­veiled a $16M seed fund­ing haul for ad­vanc­ing tech­nol­o­gy it hopes will rev­o­lu­tion­ize the stem cell man­u­fac­tur­ing in­dus­try.

CEO Nabi­ha Sak­layen found­ed Celli­no in 2017 while still in her mid-20s (she’s since gone on to be named to Forbes’ 30 Un­der 30 list and MIT Tech Re­view’s 35 In­no­va­tors Un­der 35 list), and the tech­nol­o­gy it­self us­es ar­ti­fi­cial in­tel­li­gence and a per­son­al­ized tis­sue and cell plat­form with the ul­ti­mate goal of gen­er­at­ing au­tol­o­gous-in­duced pluripo­tent stem cells at scale.

Why is this po­ten­tial­ly so im­por­tant? Right now, those type of stem cells have to be re­moved by hand, one at a time, dur­ing the man­u­fac­tur­ing process. Celli­no could be a play­er to watch go­ing for­ward.

The sec­ond piece of news came from the Covid-19 vac­cine are­na. In light of the con­tin­ued wor­ry over virus vari­ants, Glax­o­SmithK­line is dou­bling down on its Cure­Vac part­ner­ship in search of an mR­NA vac­cine of the fu­ture, my col­league Am­ber Tong re­port­ed Wednes­day morn­ing.

Backed by $180 mil­lion from GSK, the new co-de­vel­op­ment pact will see both com­pa­nies con­tribut­ing re­sources and ex­per­tise to­ward a num­ber of new mR­NA vac­cine can­di­dates — “in­clud­ing mul­ti-va­lent and mono­va­lent ap­proach­es.” The end goal here, in ad­di­tion to man­u­fac­tur­ing mil­lions of dos­es of cur­rent Covid-19 vac­cines, is for GSK to have a block­buster vac­cine of its own by 2022.

How drug com­pa­nies re­spond to Covid-19 vari­ants through their vac­cine work will be a re­al­ly im­por­tant area to watch, as vac­cines are still able to pro­tect against the new vari­ants out of the UK, South Africa and Brazil, but da­ta from the lead­ing mR­NA  de­vel­op­ers sug­gests they may not be as po­tent as they are against the orig­i­nal SARS-CoV2 (though so far, they do still quite ef­fec­tive­ly pro­tect from hos­pi­tal­iza­tions and deaths).

Since this is the first is­sue of End­points Man­u­fac­tur­ing, I al­so want to take a minute to look quick­ly at where the bio­phar­ma man­u­fac­tur­ing in­dus­try cur­rent­ly stands. Jan­u­ary, for ex­am­ple, was a month filled with rapid fa­cil­i­ty ex­pan­sion across the globe.

Lon­za, the Swiss CD­MO gi­ant, pub­licly an­nounced half a dozen fa­cil­i­ty ex­pan­sions or ac­qui­si­tions that will to­geth­er in­crease the com­pa­ny’s man­u­fac­tur­ing ca­pac­i­ty by over 20% in the com­ing years—in­clud­ing its first bi­o­log­ics fa­cil­i­ty in Chi­na and a trio of sites in Visp, Switzer­land, that for the fore­see­able fu­ture will fo­cus on API pro­duc­tion for Mod­er­na’s mR­NA vac­cine.

Those ex­pan­sions came along­side new fa­cil­i­ties at Fu­ji­film, Ther­mo Fish­er, Cog­nate and Servi­er, among oth­ers, not to men­tion the swaths of new re­al es­tate ter­ri­to­ry in the ever-grow­ing Boston biotech hub.

All this is to say, the theme here is that the CD­MO mar­ket­place shows no signs of slow­ing down. A new re­port this week from Re­search and Mar­kets projects that by 2024, the glob­al CD­MO mar­ket will reach a val­ue of $241.3 bil­lion—a 9.8% com­pound an­nu­al growth rate over just five years.

Al­so of note from Catal­ent: On Thurs­day, the com­pa­ny an­nounced an agree­ment to pro­vide Deci­bel Ther­a­peu­tics, a clin­i­cal stage biotech com­pa­ny that fo­cus­es ex­clu­sive­ly on hear­ing and bal­ance ther­a­pies, with de­vel­op­ment and man­u­fac­tur­ing ca­pac­i­ty for Deci­bel’s lead in­ves­ti­ga­tion­al gene ther­a­py can­di­date DB-OTO.

DB-OTO is a dual-vec­tor ade­no-as­so­ci­at­ed virus gene ther­a­py be­ing de­vel­oped in col­lab­o­ra­tion with Re­gen­eron Phar­ma­ceu­ti­cals (yes, the same de­vel­op­er of the in­fa­mous Covid-19 cock­tail giv­en to for­mer pres­i­dent Don­ald Trump). The mol­e­cule tar­gets those who suf­fer from sig­nif­i­cant and con­gen­i­tal hear­ing loss due to mu­ta­tions of the otofer­lin gene.

No fi­nan­cial terms were dis­closed Thurs­day, but ac­cord­ing to the agree­ment, Catal­ent will pro­vide ma­te­r­i­al from its Mary­land-based gene ther­a­py fa­cil­i­ties to sup­port Deci­bel’s planned IND-en­abling stud­ies and a Phase I/II clin­i­cal tri­al of the drug.

More on the deal from Catal­ent’s pres­i­dent of cell and gene ther­a­py, Man­ja Boer­man:

Part­ner­ing ear­ly with in­no­v­a­tive com­pa­nies al­lows us to de­vel­op and op­ti­mize ro­bust, scal­able man­u­fac­tur­ing process­es and the an­a­lyt­i­cal meth­ods to as­sess them. Our Mary­land de­vel­op­ment cen­ters in Gaithers­burg and the Uni­ver­si­ty of Mary­land BioPark in Bal­ti­more fo­cus on pro­vid­ing process op­ti­miza­tion ser­vices to meet our cus­tomers’ needs for ear­ly-stage clin­i­cal gene ther­a­pies.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Prahlad Singh, PerkinElmer

PerkinElmer hits the check­book again, this time dol­ing out $260M for next-gen ther­a­py bioser­vices firm

When PerkinElmer iced a deal to pick up UK gene editing firm Horizon Discovery, it trumpeted its big move into next-gen therapeutics. Now, not content to sit on its laurels, PerkinElmer is dipping into the war chest again, this time for a firm specializing in cutting-edge bioservices.

Life sciences services giant PerkinElmer will shell out $260 million to acquire Lawrence, MA-based Nexcelom Bioscience, which offers clinical services for next-gen cell and gene therapies, immuno-oncology drugs and vaccines, the companies said Thursday.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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